Samsung Bioepis Receives Domestic Approval for Bone Disease Treatment "Exbrick"

Securing Both Denosumab-Based Biosimilars in Korea

Samsung Bioepis announced on May 30 that it has received product approval from the Ministry of Food and Drug Safety for its bone disease treatment “Exbrick” (active ingredient: denosumab).

Exterior view of the Samsung Bioepis building located in Songdo, Incheon. Samsung Bioepis

Exbrick is a biosimilar (biologic drug copy) of “Xgeva,” developed by the global pharmaceutical company Amgen. Biologic drugs containing denosumab are divided into two products: “Prolia,” an endocrine treatment for postmenopausal osteoporosis, and “Xgeva,” a treatment for tumor diseases such as the prevention of skeletal-related events in cancer patients with bone metastases and giant cell tumor of bone.

As of last year, the combined annual global sales of Prolia and Xgeva reached $6.599 billion (approximately 970 billion KRW), while the domestic market prescription amount was about 187 billion KRW.

Samsung Bioepis has been pursuing separate product approvals for each indication, in the same way as the original drugs. Following last month’s approval of “Obodense,” the biosimilar of Prolia, the company has now obtained approval for the biosimilar of Xgeva. As a result, Samsung Bioepis now has both denosumab-based drugs available in Korea, as well as in the United States and Europe.

With this latest approval, Samsung Bioepis has increased the total number of its domestically approved products to 11. In addition, the company can now commercialize all biosimilar pipeline products that have completed global clinical trials in the domestic market.

Jung Byungin, head of the Regulatory Affairs (RA) team at Samsung Bioepis, commented, “With the approval of both Obodense and Exbrick in Korea, we are now able to offer bone disease patients the opportunity to receive treatment at a reasonable cost.”